Healthcare Industry News: Daiichi Sankyo
News Release - May 21, 2007
Data Presented at ASH Demonstrate Nebivolol Lowers Blood Pressure as Long-Term Monotherapy and in Combination TherapyData Also Show Nebivolol Lowers Blood Pressure in Obese and Non-Obese Hypertensive Patients
CHICAGO, May 21 (HSMN NewsFeed) -- Forest Laboratories, Inc. (NYSE: FRX ) today presented positive data from two clinical studies and one pooled analysis of nebivolol, a selective beta 1-blocker with vasodilating properties currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Data from the two clinical studies show that nebivolol demonstrates blood pressure lowering effects as long-term therapy either alone or in combination with other agents, and also as part of a combination treatment for hypertension. The pooled analysis of three registration monotherapy trials supports nebivolol's blood pressure lowering effects for the treatment of hypertension in obese individuals, a difficult- to-treat patient population. The data were presented at the American Society of Hypertension, Inc. (ASH) 22nd Annual Scientific Meeting and Exposition (ASH 2007) in Chicago.
Data presented at ASH includes:
The long-term treatment effects of nebivolol were evaluated in a multicenter, 9-month extension study (n=845) of patients who successfully completed one of the three randomized, double-blind, placebo-controlled registration studies. Patients received nebivolol monotherapy (5 mg, 10 mg, or 20 mg once daily) or nebivolol plus adjunct therapy (open-label diuretics or amlodipine). Outcomes demonstrated that nebivolol treatment produced sustained blood pressure reductions for the duration of the study period and was well tolerated in all treatment groups. No clinically significant changes in glucose or lipids were seen with nebivolol monotherapy during the study.
The blood pressure lowering effects and tolerability of nebivolol added to ongoing antihypertensive therapy in patients was evaluated in this 12-week, randomized, double-blind, placebo-controlled study (n=669). Results indicate that, by comparison to placebo, nebivolol incrementally lowers blood pressure in mild to moderate hypertensive patients when added to ongoing antihypertensive therapy consisting of one or two medications from the following classes: ACE inhibitors, ARBs, or diuretics, with an incidence of reported adverse events similar to placebo.
The blood pressure lowering effects of nebivolol was compared in non- obese and obese hypertensive patients, a population that typically has a poorer response to treatment and an increased need for multiple medications. The pooled analysis of three randomized, double-blind, placebo-controlled trials of similar design was stratified by patient obesity status (BMI greater than or equal to 30 kg/m2) at baseline (obese, n=878; non-obese, n=1136). Results suggest that once-daily nebivolol effectively lowers blood pressure to a similar extent in both obese and non-obese hypertensive patients. "These study results are promising and add to the growing body of data that support nebivolol as a useful treatment for hypertension across a broad population of patients," says Neil Shusterman, MD, Senior Vice President, Clinical Development, Forest Research Institute. "We feel that nebivolol will offer patients and physicians a unique option for managing high blood pressure."
Nebivolol is a selective beta 1-adrenergic (cardioselective) receptor antagonist with vasodilating properties and is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro® (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda® (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar®* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT® (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; and Campral®* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for the periods ended June 30, 2006, September 30, 2006 and December 31, 2006.
Source: Forest Laboratories
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